跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2013-004011-41-ES
EUCTR2013-004011-41-ES进行中（未招募）1 期

A Phase Ib/II, Multicentre, Open Label, Randomized Study of BI 836845 in Combination With Enzalutamide, versus Enzalutamide alone, in Metastatic Castration-Resistant Prostate Cancer (CRPC) Following Disease Progression on Docetaxel-Based Chemotherapy and Abiraterone

Boehringer Ingelheim España, S.A.0 个研究点目标入组 152 人开始时间: 2015年6月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
152
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • •1. The patient has histologically, or cytologically, confirmed adenocarcinoma of the prostate.
  • •2. Male patient aged ? 18 years old.
  • •3. Patients with radiographic evidence of metastatic prostate cancer (stage M1 or D2). Distant metastases evaluable by radionuclide bone scan, CT scan, or MRI within 28 days before the start of study treatment.
  • •4. Patients with a PSA ? 20 ng/mL.
  • •5. Patients with prior surgical or chemical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the patient must be willing to continue the use of LHRH agonists during protocol treatment.
  • •6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0, 1 or 2.
  • •7. Cardiac left ventricular function with resting ejection fraction >50% as determined by ECHO or MUGA.
  • •8. Absolute neutrophil count (ANC) ?1500/uL.
  • •9. Haemoglobin ?9 g/dL.
  • •10. Platelets ?100,000/uL.
  • •11. Bilirubin ? 1.5 times the upper limit of normal (ULN).
  • •12. Aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 times the ULN (or ? 5 times the ULN if liver metastases are present).
  • •13. Creatinine ? 1.5 x ULN.
  • •14. International normalized ratio (INR) ? 1.4 and a partial thromboplastin time (PTT) ? 5 seconds above the ULN (unless on oral anticoagulant therapy). Patients receiving fulldose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (except warfarin or
  • •coumarin-like anticoagulants, which are not permitted).
  • •15. Fasting plasma glucose < 8.9 mmol/L (< 160 mg/dL) and HbA1c < 8.0%.
  • •Inclusion criteria only for patients entering phase Ib dose escalation and phase II:
  • •16. Patients who have disease progression during, or after, receiving docetaxel and have had at least 12 weeks of treatment and in the opinion of the investigator are unlikely to derive significant benefit from additional docetaxel-based therapy, or were intolerant to therapy with this agent.
  • •17. Patients who have disease progression during, or after, receiving abiraterone treatment in any setting.
  • •18. Patients must have progressive disease defined as at least one of the following:
  • •a. Progressive measurable disease: using conventional solid tumour criteria RECIST 1.1.
  • •b. Bone scan progression: at least two new lesions on bone scan, plus a rising PSA as described in c below.
  • •c. Increasing PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required
  • •to be greater than PSA #2.
  • •Inclusion criterion only for patients entering phase Ib expansion cohort:
  • •19. Patients must be receiving continuous enzalutamide treatment and show a rise in PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2.
  • •20. Archive tumour tissue is available prior to recruitment for pharmacogenomic tests.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 120
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 32

排除标准

  • •1. Exclusion criterion 1 is not applicable for patients enrolled after protocol version 3 (or subsequent versions) are approved.
  • •2. Exclusion criterion 2 is not applicable for patients enrolled after protocol version 3 (or subsequent versions) are approved.
  • •3. Prior therapy with agents targeting IGF and/or IGFR pathway.
  • •4. Patients that have been treated with any of the following within 4 weeks of starting trial treatment: chemotherapy, immunotherapy, biological therapies, molecular targeted therapy, hormone therapy (except LHRH agonists), radiotherapy (except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within 2 weeks prior to study treatment).
  • •5. Use of any investigational drug within 4 weeks before start of trial treatment or concomitantly with this trial.
  • •6. Patients that have been treated with strong CYP2C8 inhibitors, CYP2C8 inducers, within 2 weeks of starting the trial treatment.
  • •7. QTcF prolongation > 450 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome). The QTcF will be calculated as the mean of the 3 ECGs taken at screening.
  • •8. Patients with small cell or neuroendocrine tumours.
  • •9. Patients with known or suspected leptomeningeal metastases.
  • •10. Uncontrolled or poorly controlled hypertension.
  • •11. Patients with poorly controlled diabetes mellitus. Patients with a history of diabetes are allowed to participate, provided that their blood glucose is within normal range (fasting < 160 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition.
  • •12. Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
  • •13. Patients with epilepsy, seizures, or predisposing factors for seizure as judged by the investigator.
  • •14. Patients unable to comply with the protocol as judged by the investigator.
  • •15. Active alcohol or active drug abuse as judged by the investigator.
  • •16. A history of allergy to human monoclonal antibodies.
  • •17. Patients who are sexually active and unwilling to use a medically acceptable method of contraception, e.g. condom plus spermicide use for participating males, plus another form of birth control such as implants, injectables, combined oral contraceptives, intrauterine devices for female partners, during the trial and for at least three months after end of active therapy. Men unwilling to agree to not donate sperm while on trial drug and up to 6 months following the last dose of trial drug.
  • •Exclusion criteria only for patients entering phase Ib dose escalation and phase II:
  • •18. Patients that have received prior enzalutamide in any setting will not be eligible.
  • •Exclusion criterion only for patients entering phase Ib expansion cohort:
  • •19. Patients that have received prior taxane-based chemotherapy or abiraterone in any setting will not be eligible for the expansion cohort.
  • •Additional exclusion criterion for patients undergoing tumour biopsy:
  • •20. For patients that are to undergo the tumour biopsy, a history of a hereditary bleeding disorder, or clinically relevant major bleeding event in the past 6 months, as judged by the investigator.
  • •After approval of protocol version 3 (or subsequent versions) the additional following exclusion criteria apply:
  • •For all patients:
  • •21. Previous or concomitant malignancies at any other site with the exception of the following:

研究者

相似试验

已完成
2 期
A Phase Ib/II, Multicentre, Open Label, Randomized Study of BI 836845 in Combination With Enzalutamide, versus Enzalutamide alone, in Metastatic Castration-Resistant Prostate Cancer (CRPC) Following Disease Progression on Docetaxel-Based Chemotherapy and Abirateronecastration resistant prostate cancer10038593
NL-OMON43930Boehringer Ingelheim BV6
进行中（未招募）
1 期
BI 836845 plus enzalutamide in castrate resistant prostate cancer (CRPC)Patients with metastatic castrate resistent prostate cancer (CRPC)
EUCTR2013-004011-41-NLBoehringer Ingelheim bv120
进行中（未招募）
1 期
A Study of Multiple Immunotherapy-based Treatment Combinations in Participants with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)Metastatic Pancreatic Ductal Adenocarcinoma
JPRN-jRCT2031200298Shreya Badhrinarayanan, B.M.B.S.20
进行中（未招募）
1 期
Tepotinib with Gefitinib in Subjects with Locally Advanced or Metastatic NSCLC (INSIGHT)ocally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2016-001604-28-NLMerck KGaA156
撤回
2 期
A Phase Ib/II Multicenter, Randomized, Open Label Trial to Compare Tepotinib (MSC2156119J) Combined with Gefitinib Versus Chemotherapy as Second-line Treatment in Subjects with MET Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation and Having Acquired Resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy10038666Non-small cell lung cancer
NL-OMON46330Merck2